Laser Vaginal Treatment for GSM

Not Applicable

Recruiting

• Conditions: Menopausal Urethral Atrophy; Vulvar Atrophy
• Interventions: Procedure: laser vaginal treatment

• Registration Number: NCT04042766
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

Genitourinary Syndrome of Menopause (GSM) due to low estrogen levels affects about half of post-menopausal women and may have a dramatic impact on women's quality of life. Women complain of vaginal dryness, itching, discomfort, malodour, painful intercourse and may have urinary urgency, irritation, bladder/urethral pain and recurring bladder infections. First-line therapies include vaginal moisturizers, lubricants and estrogen (either oral or with vaginal cream/tablets). While these therapies are effective, the ongoing costs and the resistance to the indefinite use of vaginal creams/inserts is a challenge to the continued use of these therapies. Recently, an innovative laser therapy has been used to treat women with GSM. A randomized controlled trial (RCT) to study how effective the laser is to treat women with GSM is planned.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-07-31
• Study Start: 2019-08-01
• Study First Posted: 2019-08-02
• Status Verified: 2023-04
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Primary Completion: 2024-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Females aged 45-70 years;
2. 2 or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy);
3. at least 1 vaginal symptom reported from the following list, experienced for the past 30 days which is moderate or severe at least once a week: dryness | itching | irritation | soreness/pain | dyspareunia;
4. no concurrent or new planned treatment for GSM during the treatment period and the 3 months following it;
5. vaginal anatomy allows for laser therapy; 6) willing and able to comply with the study protocol.

Exclusion Criteria

1. Patient is pregnant/lactating
2. unexplained abnormal genital bleeding
3. current acute vaginal/ bladder infection
4. antibiotic use the past 30 days;
5. women under age 55 with endometrial ablation/ hysterectomy/ at least one ovary;
6. concurrent use of any other new GSM treatment
7. pelvic surgery <3 months
8. current treatment for chronic pelvic pain

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laser treatment	laser vaginal treatment	-
sham treatment	laser vaginal treatment	-

Primary Outcome Measures

Name	Time	Method
subjective measure of change in: the patient's most bothersome symptom	Baseline and 3 months after treatment start	The most bothersome symptom of GSM (vaginal dryness, discomfort, itching, dyspareunia, urinary urgency, dysuria) will be identified and its severity rated on a standardized 4-point scale: 0=none, 1=mild, 2=moderate, 3=severe

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre, University of Toronto; 🇨🇦 Toronto, Ontario, Canada